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Dec. 16, 2015, 8:24 AM
- Soligenix (OTCQB:SNGX) announces positive results from a Phase 2 clinical trial assessing SGX942 for the treatment of severe oral mucositis (OM) in patients undergoing chemoradiation therapy (CRT) for head and neck cancer.
- Patients receiving 1.5 mg/kg of SGX942, a synthetic peptide called an innate defense regulator that modulates the body's reaction to injury and infection, experienced a median reduction in the duration severe OM of 50% (18 days to nine days; p=0.099) while those undergoing the most aggressive CRT showed a median duration reduction of 67% (30 days to 10 days; p=0.040).
- The data will be submitted for publication and presentation at a future scientific conference.
- OM usually occurs in the mouth of patients undergoing anticancer therapies. It affects ~500K Americans or 40% of those receiving chemo and almost all head and neck cancer patients receiving chemoradiation.
- The FDA has designated SGX942 for Fast Track review for the indication.
- The company will host a conference call this morning at 9:00 am ET to discuss its recent clinical trial results and development milestones.
- OM-related tickers: (OTCPK:CTIX)(NASDAQ:AMAG)(NYSE:XON)(NYSEMKT:OGEN)(NASDAQ:SCMP)
Dec. 3, 2015, 12:40 PM
- Thinly traded nano cap Soligenix (OTCQB:SNGX -27.5%) slumps again today on a 5x surge in volume. Shares are down over 40% over the past two days on no particular news.
- The company is sponsoring one ongoing clinical trial, a Phase 2 evaluating Fast Track-tagged SGX942, a 5-amino acid peptide, for the treatment of oral mucositis (OM) in head and neck cancer patients undergoing chemo and/or radiation treatment. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint, improvement in OM symptoms four weeks after the end of therapy, is December 2015. The estimated study completion date is August 2016.
- On November 25, the FDA designated Cellceutix's (OTCPK:CTIX) Phase 2-stage oral rinse, Brilacidin-OM, for Fast Track review for OM. The oral rinse formulation presents a distinct advantage over SGX942's intravenous route of administration.
- A Phase 3 study evaluating SGX301, photoactivated hypericin, for the treatment of cutaneous T-cell lymphoma is set to begin shortly. The primary endpoint is the response in three treated lesions defined as at least a 50% improvement in CAILS score (a composite measurement) compared to placebo. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2016. The estimated study completion date is October 2017. SGX301 is designated an Orphan Drug in both the U.S. and Europe for the indication.
- Previously: Cellceutix's Brilacidin-OM Fast Track'd for oral mucositis (Nov. 25)
Dec. 1, 2015, 12:26 PM
- Cellceutix (OTCPK:CTIX +1.2%) announces that it has received Rare Pediatric Disease Designation from the FDA for Orphan Drug-tagged Kevetrin for the treatment of retinoblastoma, a rare type of eye cancer that originates in the retina.
- The big benefit of the designation is the opportunity to apply for a Rare Pediatric Disease Review Voucher, which can be used for Priority Review (six months) of a future NDA or can be sold to a third party. The vouchers are quite valuable. In 2014, AbbVie (ABBV +0.6%) bought one from United Therapeutics (UTHR +2.7%) for $350M in cash.
- Kevetrin is a small molecule that induces the activation of the tumor suppressor protein p53.
Nov. 25, 2015, 9:10 AM
- The FDA designates Cellceutix's (OTCPK:CTIX) Phase 2-stage oral rinse Brilacidin-OM for Fast Track review for the prevention of oral mucositis, a common and debilitating inflammation and ulceration in the mouth that occurs as a side effect of certain cancer treatments. There is only one approved therapy for the condition, AMAG Pharma's (NASDAQ:AMAG) MuGard oral rinse.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint (WHO OM Score) in the 60-subject Phase 2 trial is June 2016. The estimated study completion date is December 2016.
- Fast Track status allows for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
Aug. 3, 2015, 9:26 AM
- Cellceutix (OTCPK:CTIX) announces ongoing enrollment of the Phase 2 trial of Brilacidin-OM for oral mucositis in patients with head and neck cancer. The company has added two clinical sites, bringing the total number of clinical sites employed in the trial to five.
- Two successfully completed Phase 2 clinical trials of Brilacidin for Acute Bacterial Skin and Skin Structure Infections have demonstrated its ability to rapidly destroy bacteria.
Jul. 17, 2015, 12:37 PM
- Thinly traded Cellceutix (OTCPK:CTIX +12.9%) heads north again on increased volume. Shares are up over 30% the past three trading days. The party got started on Wednesday when the company announced that the FDA designated Kevetrin an Orphan Drug for the treatment of ovarian cancer.
- Kevetrin, a small molecule compound currently in Phase 1 development, induces the activation of a tumor suppressor protein called p53.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Apr. 1, 2015, 8:59 AM
- Cellceutix (OTCPK:CTIX) secures a stock purchase agreement with Aspire Capital Fund, LLC under which it has committed to buy up to $30M of CTIX common stock over the next three years at market prices. The timing of the purchases is at the sole discretion of Cellceutix.
- Aspire previously provided the company with $30M in equity capital in two similar transactions.
Jan. 20, 2015, 1:11 PM
- Micro cap Cellceutix (OTCPK:CTIX +17.8%) jumps on a 2x surge in volume in response to its announcement of the complete disappearance of a metastatic lesion in the spleen of a Stage 4 ovarian cancer patient who was enrolled in the company's Phase 1 study of Kevetrin. The patient completed three cycles of treatment (three doses per cycle) before discontinuing the trial. Scans of the spleen showed the lesion to be essentially undetectable and the patient's disease clinically stable. The clinical trial is ongoing.
- Kevetrin is a small molecule drug that induces the activation of p53, a tumor suppressor protein often referred to as the "Guardian Angel Gene" because of its prominent role in controlling cell mutations.
Dec. 29, 2014, 7:28 AM
- Cellceutix (OTCPK:CTIX) appoints Daniel Jorgensen, MD, MPH, MBA as Chief Medical Officer effective January 1. He previously served as a consultant to the company.
Dec. 8, 2014, 1:23 PM
- Micro cap Cellceutix (OTCPK:CTIX +22.1%) jumps on a 5x surge in volume after the FDA grants Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The company is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.
- Brilacidin is a member of a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the "front line" of defense in the human immune system.
- In a Phase 2b clinical trial, a single dose of Brilacidin demonstrated equivalent effectiveness as a seven-day regimen of daptomycin (CBST +35.4%) for the treatment of ABSSSI.
- Among the benefits of QIDP is Fast Track and Priority Review status and a five-year period of market exclusivity if approved.
Oct. 13, 2014, 10:31 AM
- The IND for Cellceutix's (OTCQB:CTIX +2.3%) Brilacidin-OM is now effective which clears the way for a Phase 2 trial in patients with oral mucositis.
- MD Anderson Cancer Center signs on as a clinical trial site.
- Oral mucositis is a cancer therapy side effect that afflicts ~500K head and neck cancer patients. There are currently no drugs approved in the U.S. for the indication.
Aug. 19, 2014, 9:45 AM
- Cellceutix (OTCQB:CTIX) completes enrollment of 215 subjects in its Phase 2b clinical trial comparing Brilacidin to Cubicin (daptomycin) in patients with acute bacterial skin and skin structure infections (ABSSSI). The company expects data to be available in Q4.
- Brilacidin is a defensin-mimetic antibiotic. This new class of drug kills bacteria in the same manner as the human immune system.
- Related ticker: (CBST +0.2%)
Jul. 14, 2014, 8:18 AM
- Cellceutix Corp. (OTCMKTS:CTIX) develops a new formulation of its lead antibiotic Brilacidin that is stable at room temperature. This enables the company to move forward with its plans to develop the defensin-mimetic antibiotic as a treatment for diabetic foot ulcers and ophthalmic and otitis media indications.
Jul. 7, 2014, 8:11 AM| Jul. 7, 2014, 8:11 AM | 13 Comments
Sep. 16, 2013, 8:08 AM
- Cellceutix Corporation (CTIX.OB) says it will "immediately advance" Brilacidin — the defensin-mimetic antibiotic acquired in the recent deal for PolyMedix — to a Phase 2b clinical trial for acute bacterial skin and skin structure infections.
- The company also says the compound may be effective for oral mucositis and as such, CTIX plans to finalize an IND and pursue an orphan designation for the treatment.
- Ultimately, the company sees quite a few exciting opportunities for the assets acquired from PolyMedix: "We believe we hit a home run with the PolyMedix acquisition, especially as it pertains to Brilacidin. The reality of owning these assets is now beginning to set in." (PR)
- More on Brilacidin here
An early stage developmental biopharmaceutical company...with six pharmaceutical compound candidates that are designed for treatment of diseases which may be either existing or diseases identified in the future. The Company will initially spend most of its efforts and resources on its... More
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